The U.S. FDA has developed an 'Abbreviated New Drug Application' (ANDA) pathway to enhance access to lower-cost generic drugs.
The demand for affordable peptide drugs like Ozempic and Wegovy has spurred generic drug development.
The ANDA pathway simplifies the review process for generic drugs while maintaining quality and safety standards.
Sponsors must identify and characterize impurities in generic formulations that differ from the reference listed drugs.
is a key focus of the ANDA pathway, requiring orthogonal methods for assessment.
Several methods for assessing immunogenicity risk of generic peptide impurities are described and compared to existing techniques.
Simplified
Generic drugs have saved consumers billions of dollars in the United States. The demand for lower-cost and effective drugs, particularly for well-known peptide drugs like Ozempic and Wegovy (brand names for semaglutide), has resulted in a surge of generic drug development to address perceived shortages in the supply of the reference listed drugs (RLD). To address this demand for generics and expedite consumer access to lower-cost generic versions of approved drugs, the U.S. Food and Drug Administration (FDA) has developed an "Abbreviated New Drug Application" (ANDA) pathway that simplifies the generic drug review process and expands access to these much-needed medicines without compromising quality and safety standards. Guidelines for this pathway require sponsors to identify and characterize both process- and product-related impurities in drug formulations that differ in nature or concentration from the RLD. The ANDA pathway devotes specific attention to and recommends the use of orthogonal methods of assessment to demonstrate that a proposed generic drug is immunologically equivalent to its RLD and therefore suitable for submission via the ANDA pathway. In this perspective, we describe several orthogonal methods for immunogenicity risk assessment of generic peptide impurities and contrast these with other methods such as MHC-Associated Peptide Proteomics peptide elution (MAPPs) assays. Given their importance in the generic drug approval pathway, we have submitted the "PANDA" immunogenicity risk assessment methods as a 'model master file'. ®
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Declarations. Conflict of Interest: ADG and WDM are senior officers and majority shareholders of EpiVax, Inc, a privately owned immunoinformatics and vaccine design company. ADG, BG, AM, WDM, JC, BR, SL, CB, GR, and MM are employees of EpiVax, Inc. Due to this relationship with EpiVax, these authors acknowledge that there is a potential conflict of interest inherent in the publication of this manuscript, and attest that the work contained in this research report is free of any bias that might be associated with the commercial goals of the company.
PubMed
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